Quality Assurance Associate

🌟 We're Hiring: Quality Assurance Associate! 🌟

We are seeking a detail-oriented and dedicated Quality Assurance Associate to ensure the highest quality standards in our products and services. The ideal candidate will have extensive experience in QA processes, testing methodologies, and a commitment to excellence in delivering customer satisfaction.

📍 Location: Holly Springs, United States
⏰ Work Mode: Work From Office
💼 Role: Quality Assurance Associate

Job Description:
Reporting to the Batch Release Manager, the QA Specialist supports review of batch documentation and release of internal and external commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Ability to prioritize record review and usage decisions to support business needs and communicating release needs throughout the organization.

Job Specific Responsibilities
1. Batch Release
2. Responsible for certification and/or rejection of incoming material and manufactured material in compliance with applicable licenses and legal requirements. Ensures compliance with regulatory requirements, internal/external guidelines, SOPs, and specifications related to record review and product release. Ability to identify non-compliances impacting release and report/escalate as appropriate for resolution.
3. Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities. Authors, reviews, and QA approves Standard Operating Procedures (SOP’s), protocols/reports, work instructions, etc.
4. Creates and maintains QA SAP Master Data builds in support of batch release.
5. Data population and approval of Lot Release Protocols. Supports Lot Release Protocol revisions and GLIMS data builds for LRPs.
6. Additional job responsibilities may be assigned.

What We're Looking For:
✅ Must have familiarity with SAP; strong preference for candidates who have used SAP for batch release in a prior role.
✅ 5 years’ related experience in Pharma Quality.
✅ Strong organization, administrative and data entry skills.

Preferred/Nice-To-Have:
✅ Experience using Veeva and/or GLIMS

Ready to make an impact? 🚀 Apply now and let's grow together!